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Regulations

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12Jul 2024
EU, Regulations Cubicdesignz

Implant Cards for Europe

The European Union’s Medical Device Regulation (MDR 2017/745) introduces a new requirement for manufacturers producing implant cards for medical devices. As per EU MDR, implantable devices are any devices, other than the active implantable devices, that are partially or completely implanted into the human body or are used to replace an epithelial surface or the surface of the eye, by clinical intervention, and are meant to stay in place after the procedure. The device that is intended to be pa...
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12Jul 2024
EU, Regulations Cubicdesignz

Importance of Human Translations vs Machine Translations

Human translation Human translations produce accurate results because it involves at least one language expert. Translations, with a human touch to them, are precise because of the in-depth knowledge that translators carry Human translations are done by native speakers of a particular language or people certified in language translations . Therefore, it is culturally diverse, nuanced and is of high quality. However, this high-quality product is expensive. Machine translation Machine transla...
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12Jul 2024
EU, Regulations, Swiss, UK Cubicdesignz

UDI DI

UDI-DI On 5 May 2017, the EU published the new EU MDR 2017/745 and IVDR 2017/746 regulations in which they formally introduced the UDI system in the EU. The UDI comprises the following components The Basic UDI-DI is a technique introduced by the EU for linking medical devices to their regulatory documentation so that the model of the product can be uniquely identified throughout its entire lifecycle. The linked documentation may include the declaration of conformity, notified body certificates,...
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12Jul 2024
EU, Regulations admin

EU MDR – Article 117

EU MDR – Article 117 – The French Poly Implant Prostheses (PIP) breast implant controversy prompted medical rules to be revised and formed new Medical Devices and In-Vitro Devices Regulations to safeguard public health. As per the European Medicines Agency (EMA) definition, a medicinal device is a substance or combination of substances intended to treat, prevent or diagnose a disease, or restore, correct or modify physiological functions by exerting a pharmacological immunological...
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12Jul 2024
EU, General Information, Regulations Cubicdesignz

Smart Wearables Regulations in the EU 

The booming technological aspects have constantly challenged regulations established worldwide in the modern century because the regulations either inadequately govern novel technologies, or there always exists a scenario where the devices cannot be categorized within a given regulation. Smart wearables are one of those aspects falling into such debate in recent times. Days are no longer from the fact that these smart wearables may draw strict regulations to be in place. How are these general we...
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12Jul 2024
Brazil, Regulations admin

Updates in ANVISA GMP 2022 document 

Agência Nacional de Vigilância Sanitária – ANVISA is the Regulatory Body of Brazilian government.   What is Good Manufacturing Practice (GMP)?  Good manufacturing practices are the procedures that must be followed in order to comply with the guidelines set forth by regulatory agencies that oversee the authorization and licencing of the manufacture and sale of medical devices.  The GMP document released on 30th March 2022 for Medical and IVD produ...
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05Feb 2024
Regulations Cubicdesignz

Regulatory Pathway for Clinical Investigation In the UK

Clinical investigation creates a set of clinical data that is crucial to understanding the effectiveness of a medical device. Clinical Investigation is done for devices that are previously UKCA / CE / CE UKNI marked or for research medical devices. It is governed by a clinical investigation plan with an objective, methodology, and record keeping. Steps involved in Clinical Investigation in UKCA Step 1: Ensure all the information necessary to demonstrate compliance with all the relevant esse...
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05Feb 2024
Regulations Cubicdesignz

Different Levels Of Labelling

The different levels of labelling are related to the different levels of packaging. There are 3 levels of packaging which corresponds to the levels of labelling. 3 Levels of Packaging corresponds to Levels of Labelling Primary Packaging (Levels of Labelling) The Primary packaging is the packaging that most closely touches a product and is often referred to as “retail packaging.” Its main goals are to ensure the protection of the product of all the medical devices and inform or...
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05Feb 2024
Regulations Cubicdesignz

ISO 15223-1: 2016

Many countries demand that medical devices provide textual information in their local language. When different languages are incorporated on a single label or piece of paperwork, this can cause issues with translation, design, and logistics. Users of medical devices that are labelled in a variety of languages may get confused, and delay in locating the proper terminology can occur. As a result, internationally recognised symbols with well specified definitions were established to address these i...
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05Feb 2024
Regulations Cubicdesignz

Importance of Human Translations vs Machine Translations

Human translation Human translations produce accurate results because it involves at least one language expert. Translations, with a human touch to them, are precise because of the in-depth knowledge that translators carry Human translations are done by native speakers of a particular language or people certified in language translations . Therefore, it is culturally diverse, nuanced and is of high quality. However, this high-quality product is expensive. Machine translation Machine transla...
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